CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus
CrossBay Medical, Inc., a health technology company focused on improving the delivery of women’s healthcare, announced it has received clearance from the Food and Drug Administration (FDA) to market its CrossGlide ETS Plus.
Similar to the CrossGlide ETS, Endometrial Tissue Sampler (which received FDA clearance this summer), the ETS Plus also enables medical providers to perform a frictionless, office-based endometrial biopsy procedure gently, effortlessly and without a tenaculum. This new ETS Plus device is also indicated for use for sonohysterography for real-time diagnostic visualization in addition to the removal of material from the uterus and from the mucosal lining of the uterus to obtain tissue for histological biopsy.
The CrossGlide ETS Plus is the fourth product to utilize the frictionless CrossGlide technology platform. All CrossGlide platform products are designed to provide simpler access to the uterine cavity than currently available modalities.
Sonohysterography procedures use soundwaves to produce pictures of the inside of the uterus and help diagnose conditions ranging from infertility to diagnosing potential causes of uterine bleeding. To perform the procedure, the healthcare professional injects a small amount of sterile saline into the cavity of the uterus to study the lining of the uterus using the ultrasound transducer. The procedure is performed in women’s health offices worldwide, but can often be uncomfortable for the patient. The CrossGlide ETS Plus is uniquely designed to require no grasping or manipulation of the cervix to allow for easy, dependable access into the uterine cavity even in complex patient anatomy.
“The FDA’s approval of CrossGlide ETS Plus marks yet another step in our company’s development,” said Piush Vidyarthi, CrossBay Medical’s CEO. “Uterine access in the office doesn’t have to be painful for patients. I regularly read statements or presentations by doctors and companies stating they have found a way, using antiquated tools, to make a procedure less painful. This, however, doesn’t meet the paramount goal, which should be to achieve patient comfort during office-based procedures. With CrossGlide, we are providing the tools for a movement to make women’s care a significantly more comfortable experience for patients. It is gratifying to be able to make CrossGlide ETS Plus available to US clinicians and their patients, and further that mission.”
The CrossGlide ETS and ETS Plus biopsy devices have received issued US patents, with additional patents for the technology platform pending in the US and worldwide. Patent information can be found at crossbaymedicalinc.com.
Vidyarthi noted that CrossBay plans to develop products for other office-based gynecology procedures using CrossGlide wherever cervical access is required, including products for IUD insertion.
See Full Press Release at the Source: CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus | Business Wire
Press Release by: CrossBay Medical
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